Device and method for performing end-to-side anastomosis

ABSTRACT

Devices, methods, and kits are provided for suturing an end of a first body duct to a hole in the side of a second body duct. The present devices and methods are used to simplify the suturing procedure and thus reduce operating time. In one embodiment, the present device includes a structure for holding the end of the first body duct and positioning the end adjacent to the hole in the side of the second body duct. The structure of the device is typically a shaft having a surface adapted to receive the first body duct. A plurality of needles are arranged on the structure to be advanced along a plurality of paths. Each needle path first passes radially into and forwardly out of the end of the first body duct and into the hole of the second body duct. The path then everts so that the needles and associated sutures will pass outwardly through tissue peripheral to the hole when the end of the first body duct is on the structure adjacent to the hole in the second body duct. The needles preferably travel along such paths when they are advanced forward. In one embodiment, the device uses a J-shaped tube for guiding one of the needles along the desired path. In another embodiment, shape-memory needles having an arcuate profile are used to create the desired path.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a in continuation divisional of Application Ser. No.09/395,901, filed on Sep. 14, 1999 now U.S. Pat. No. 6,358,258.

BACKGROUND OF THE INVENTION

The present invention relates generally to devices and methods forsuturing body tissue. More particularly, the present invention is usefulfor performing end-to-side attachments of body ducts, such as insuturing coronary blood vessel grafts.

In many medical procedures today, it is desirable to connect a bodyduct, such as a hollow organ or blood vessel, to a targeted piece oftissue. In coronary surgery, this type of attachment is commonlyreferred to as an anastomosis. In certain heart operations wherecoronary artery bypass graft surgery (“CABG”) is performed as shown inFIG. 1A, a graft blood vessel G may be affixed to a port or aperture inan arterial wall of an artery to supply blood downstream of a blockagein another blood vessel V. The proximal end of the blood vessel graft istypically connected to a pressurized arterial blood supply, such as theaorta A, while the distal end is coupled to the vessel lumen downstreamof the blockage. The amount of time spent performing these anastomosisprocedures to connect blood vessel grafts between blocked arteries andpressurized blood supplies is critical to patient mortality andmorbidity. In conventional CABG surgery, three critical determinatesthat affect the outcome of a bypass surgery are (1) time the patientspends on cardiopulmonary bypass, (2) time the patient spends with aclamped aorta, and (3) the quality of the anastomosis. It is generallyunderstood that the risk of patient morbidity rises significantly aftera threshold time of one hour on cardiopulmonary bypass. Continualcirculation of blood through the mechanical apparatus of the bypassmachine can cause various degradations to the blood. Perhaps the mostprevalent complication arising from prolonged cardiac bypass is the highrisk of distal thrombosis, which can embolize into the neurovasculatureand potentially cause a stroke.

A critical factor in reducing the amount of time a patient spends onbypass is directly related to the time spent anastomosing the bloodvessel grafts used during surgery. The average time for suturing oneanastomosis is approximately seven to ten minutes. It is believed thatan average CABG procedure involves approximately five anastomoses.Therefore, the average time for graft suturing ranges from thirty-fiveto fifty minutes, which is a significant portion of the sixty-minutethreshold for patient morbidity. Patients treated with conventionalcoronary surgery and placed on cardiopulmonary bypass would benefit fromreducing the amount of time spent performing each anastomosis.

In “off pump” procedures where patients are not placed oncardiopulmonary bypass and the heart remains beating, the difficulty ofsuturing an anastomosis graft on a moving surface of the heart maydegrade the quality of such grafts completed on patients. “Off pump”procedures do not use cardiopulmonary bypass pumps or devices and thusreduces the blood damage associated with bypass devices. “Off pump”procedures, however, requires a higher degree of expertise to performcoronary artery bypass grafts on a beating or moving object. Ananastomosis differs from straight line suturing in that each suture hasa different orientation that is based on its position around thecross-sectional circumference of the blood vessel graft. It can beappreciated that some of the sutures are easily made from on top of theconduit or blood vessel graft, while others are more difficult tocomplete as they are beneath the conduit. It can be further appreciatedthat performing such complex suturing procedures on a moving platform,such as the beating heart, further increases the difficulty associatedwith such suturing procedures. Improperly connecting blood vessel graftsto the patient may present substantial post-operative complicationsand/or increase operating room time spent correcting the improperlyconnected graft.

Accordingly, it would be desirable to provide improved devices andmethods that simplify anastomosis graft procedures performed onpatients, particularly where multiple graft procedures are to beperformed. Simplifying the anastomosis procedure would typically reducethe time spent on each graft and thus minimize the time a patient spendson cardiopulmonary bypass. Additionally, it would desirable to provide adevice that improves the consistency of the suture pattern createdduring each anastomosis graft.

SUMMARY OF THE INVENTION

The present invention comprises systems, methods, and kits forfacilitating the suturing of one body duct to another body duct ortissue surface. The present invention simplifies suture delivery,reducing the amount of time required for performing an anastomosis andfacilitating the delivery of suture needles through blood vessels. Thepresent invention may be used in a variety of environments and isapplicable to both stopped heart and beating heart procedures. Theprevent invention may be used in a minimally invasively environmentusing percutaneous ports such those developed by Heartport, Inc. ofRedwood City, Calif. or retractor systems developed by Cardio ThoracicSystems of Cupertino, Calif. Of course, the present invention may alsobe used in an open surgery environment.

The present invention preferably allows the delivery of a plurality ofneedles through both body ducts in a single continuous motion by theuser. Advantageously, this simplified needle/suture delivery reduces theamount of time spent on performing body duct connections such as ananastomosis. In situations where the invention is used with a beatingheart, the invention allows for rapid actuation once the device isproperly positioned, reducing the likelihood that movement of thebeating heart may misposition the device during actuation. The presentinvention further allows for the simultaneous delivery of a plurality ofneedles through the body ducts in an evenly-spaced manner which thusimproves the quality of the anastomosis by having a consistent suturepattern and a calculated tissue capture. The present invention is alsoparticularly useful when targeting a pressurized blood vessel when it isdesirable to maintain hemostasis at the targeted suture site.

In one aspect of the present invention, a device is provided forsuturing one end of a first body duct to a hole in the side of a secondbody duct. When performed during coronary surgery, such connections ofthe body ducts are known as end-to-side anastomoses. The deviceaccording to the present invention includes a structure for holding theend of the first body duct and positioning the end adjacent to the holein the side of the second body duct. The structure of the device istypically a shaft having a surface adapted to receive the first bodyduct. The first body duct used during anastomosis is typically some typeof tubular graft such as a saphenous vein while the second body duct isthe targeted blood vessel. Further examples of first and second bodyducts are provided in the detailed description below.

A plurality of needles are arranged on the structure to be advancedalong a plurality of paths. FIG. 1B depicts preferred paths according tothe present invention. Each needle path first passes radially into andforwardly out of the end of the first body duct and into the hole of thesecond body duct. The path then everts so that the needles andassociated sutures will pass outwardly through tissue peripheral to thehole when the end of the first body duct is on the structure adjacent tothe hole in the second body duct. The needles preferably travel alongsuch paths when they are advanced forward. The structure of the devicetypically includes a plunger which may be translated to advance theneedles forward through the first body duct. The plunger may includesuture storage area for sutures attached to the needles.

The needle paths of the present invention may be defined in a variety ofmanners. In one embodiment of the present invention, a plurality ofguide channels are provided to define the path of the needles. Thechannels may be integrally formed in the device structure or they may beindividual guide tubes. The guide channels typically have a firstportion and a second portion where the first and second portions areseparated by a gap which receives the end of the first body duct. Thefirst portion of the guide channel is adapted to be positioned outsidethe first body duct and has a distal opening positioned to open towardsan outer surface of the first body duct when the first body duct ismounted on the structure, between the gap. The second portion of theguide channel is adapted to be positioned in the lumen of the first bodyduct when the first body duct is mounted on the structure within thegap.

The needles are advanced from the first portion of the guide channel topass through the body duct wall and into the second portion of the guidechannel. The needles are preferably of sufficient length to extendthrough the guide channels and through the tissue layer of the secondbody duct. The second guide channel preferably has a J-shaped section toguide the needle along the desired path. The needles passing through theJ-shaped section will assume an everted configuration directing theneedles toward peripheral tissue around the hole in the second bodyduct. The guide channel or tube may also have a longitudinal slotextending along a portion of the channel or tube to facilitate removalof the suture once the needle has been removed from the guide channel.To facilitate delivery through the curved portions of the guide channel,the needles used in the guide channels are typically made of materialssuch as a shape-memory alloy or a superelastic material.

In another embodiment of the suturing device, the present invention usesa plurality of needles having an arcuate profile-when unconstrained todefine the needle path. The needles are constrained by a tubularconstraint on the structure and the needles are movable between a firstposition and a second position. In the first position, the tubularconstraint maintains the needles in a substantially straightconfiguration. In the second position, the needles are advanced forwardand extend beyond the tubular constraint, assuming the arcuate profile.The tubular constraint typically comprises an outer tube and an innertube. The outer tube has a passage with the inner tube slidably mountedwithin that passage. As seen in the figures, the tubes are typicallycoaxially aligned and have a slideable relationship relative to eachother. In this embodiment, the needles are fixedly secured to the distalend of the inner tube so that the needles are adapted to penetrate oneend of the first body duct when the body duct is mounted within theinner tube. When the needles assumes the arcuate profile, the sharpeneddistal tips of the needle preferably point in a proximal directiontowards tissue peripheral to the hole in the second body duct.

In another aspect of the present invention, a method is provided forsuturing one end of a first body duct to a hole in the side of a secondbody duct. Although not limited in this manner, such suturing isparticularly suited for performing an anastomosis graft during coronarysurgery. The method involves positioning one end of the first body ductadjacent to the hole in the second body duct. A plurality of needles areadvanced, carrying a plurality of sutures along a plurality of paths.Needles following each path first passes radially into and forwardly outof the end of the first body duct and into the hole of the second bodyduct and then everts to pass outwardly through tissue peripheral to thehole when the end of the first body duct is on the structure adjacent tothe hole in the second body duct. A portion of at least one of thesutures is secured outside of the first body duct to a portion of thesuture outside of the peripheral tissue surrounding the hole in thesecond body duct. Typically, the first body duct is mounted against ashaft structure containing the plurality of needles. This may involveplacing the body duct over a portion of the shaft structure or placingthe body duct within a lumen of the shaft structure.

The method typical involves advancing a plunger or similar device todrive the needles along the desired path. In one embodiment, advancingthe needles involves passing the needles through guide channels whichdefine the paths. The guide channels each have a first portion and asecond portion, where the first and second portions are separated by agap which receives the end of the first body duct. Advancing the needletypically comprises passing the needle through the first portion of theguide channel, through the wall of said first body duct, and into thesecond portion of the guide channel. As the needles are advanced, theywill also be everted. The second portion of the guide channel has acurved portion which will bend the needle to have a partially evertedconfiguration. Securing the sutures involves removing the sutures fromthe guide channels by lifting the sutures out of the channels through alongitudinal slot running along a length of at least one of the guidechannels.

In another embodiment, the prevent invention provides another method foreverting the needles as they are advanced. The needles used in thismethod have arcuate profiles when unconstrained. The everting comprisespassing the needles forwardly from a tubular constraint so that theneedles assume an everted configuration as they are passed forwardly.Typically, the method involves providing a suturing device having twocoaxially-mounted tubes where at least one of the needles is made of ashape-memory alloy and is mounted on the inner tube. The needles areextended beyond the outer tube by relative motion between the needle andthe outer tube where the needle is extended to the arcuateconfiguration, preferably where a sharpened tip of the needle pointssubstantially in a proximal direction. It may be necessary to lift theshaft structure in a proximal direction to pull the needles through theperipheral tissue surrounding the hole in the second body duct.

Kits according to the present invention will comprise a graft suturingdevice which delivers a plurality of needles. The kits will furtherinclude instructions for use setting forth a method as described above.Optionally, the kits will further include packaging suitable forcontaining the graft device and the instructions for use. Exemplarycontainers include pouches, trays, boxes, tubes, and the like. Theinstructions for use may be provided on a separate sheet of paper orother medium. Optionally, the instructions may be printed in whole or inpart on the packaging. Usually, at least the graft suturing device willbe provided in a sterilized condition. Other kit components, such as thegraft to be sutured, may also be included.

A further understanding of the nature and advantages of the inventionwill become apparent by reference to the remaining portions of thespecification and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows one blood vessel grafted onto various blood vessels of theheart;

FIG. 1B is a cross-sectional view showing the suture path used toconnect two body ducts together;

FIG. 2 depicts a preferred embodiment of the present invention having aplurality of needles extended in a substantially curved configuration;

FIGS. 3–7 show the loading of a body graft and needle delivery using adevice as illustrated in FIG. 2;

FIG. 8 shows another embodiment of the suturing device according to thepresent invention;

FIG. 9 illustrates internal mechanisms of the suturing device shown inFIG. 8;

FIG. 10 is a cross-sectional view of a first tube containing the needleand drive tube;

FIGS. 11–12 illustrate needle delivery through two body ducts using thedevice of FIG. 8;

FIGS. 13–14 show the various hypotubes used to guide needles used in thedevice of FIG. 8; and

FIG. 15 shows a kit according to the present invention.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

The present invention is directed towards devices and methods forfacilitating the suturing of one body duct to another body duct. Inparticular, the present invention will facilitate the end-to-side orend-to-end anastomosis of a vascular graft such as a saphenous vein to atarget artery such as the aorta or similar blood vessel. Usually, avascular graft will have a width in the range from 2 mm to 8 mm, whilethe target will have a width from 2 mm to 5 mm. The aorta will have awidth from 20 mm to 40 mm. As described below, devices of the presentinvention can preferably deploy a plurality of needles in an evenlyspaced or otherwise predetermined configuration to perform theanastomosis. In exemplary embodiments, a device of the present inventioncan position the suture for performing the end-to-side anastomosisthrough one hand stroke or step by the user. Deployment of a pluralityof needles in a predetermined pattern increases the likelihood that theanastomosis will have sufficient patency to channel blood as desired andhave reduced incidence of fluid leakage. More importantly, however, thepresent device will reduce the amount of time a patient spends on acardiopulmonary bypass, which has a direct relationship to a patient'soperative and peri-operative morbidity. The reduced number of stepsrequired for a user to perform the anastomosis also lends the presentdevice for use in beating heart or off-pump procedures.

The term “body duct” as used herein is generally in reference to a bloodvessel such as those listed on Table 1. It should be understood,however, that the term is intended to cover a variety of body lumens andmay refer to non-vascular body lumens such as the bile duct, theurethra, the urinary bladder, or other body lumens which requireassistance to be rejoined. Graft vessels and ducts can be natural orsynthetic, preferably being natural vessels obtained from the patientbeing treated. Typically target blood vessels and graft vessels areprovided in the table below.

TABLE 1 TARGET VESSELS GRAFT VESSELS Coronary arteries Internal mammaryartery Coronary artenes Saphenous veins Aorta Saphenous veins Femoralartery Saphenous veins Popliteal artery Saphenous veins

The present invention is particularly useful in attaching a tubulargraft to the side of another tissue structure as shown in FIG. 1B. Thepresent invention relies on delivering a plurality of needles throughthe body ducts along a substantially everted J-shaped or hooked suturepath P as shown in FIG. 1B. Each path P first passes the needle radiallyinto and forwardly out of the end of the first body duct and into thehole of the second body duct and then everts so as to pass outwardlythrough tissue peripheral to the hole when the end of the first bodyduct is on the structure adjacent-to the hole in the second body duct.This advantageously allows the graft body duct to be connected to thetargeted body duct in a minimal amount of time using sutures, whilepossibly increasing the quality and accuracy of the luminal graft.

In particular, the present invention provides devices, kits, and methodsfor their use which deliver the sutures along defined paths in relationto blood vessels or other body ducts. The paths will each include aninitial portion 10 where the suture is introduced radially inwardly sothat it passes into the distal lumen of a first body duct, usuallywithin 0.25 mm to 1.5 mm of the distal terminus 13. The distal terminusof the first body duct will be positioned adjacent to-the hole 14 in thesecond body duct 15, and the sutures will pass inwardly through the holeand will then evert along radially outward portions 16. Such evertingpaths allow the suture to pass through a peripheral edge 17 of the wallof the second body duct 15 surrounding the hole 14, typically within0.25 mm to 1.5 mm of the hole. Usually from 4 to 20 sutures will bepositioned, preferably from 8 to 12. Usually, but not necessarily,sutures will be positioned simultaneously. After positioning, suturescan be individually tied off to complete the anastomotic attachment.

Referring now to FIGS. 2–7, one embodiment of a suturing device 10 foruse in coronary graft anastomosis will be described in further detail.Although the remainder of the application discusses the invention incoronary surgery environment, it should be understood, of course, thatthe device can be adapted for use in a variety of other surgicalsettings such as laparoscopic environments and the like. As shown inFIG. 2, the suturing device 10 has a shaft structure 20 for deploying aplurality of needles 30 to perform the anastomosis. The needles 30 aretypically mounted in a radial configuration about the shaft structure20. The radial configuration is used to improve tissue capture andspacing during suture placement and needle deployment. In the presentembodiment, the shaft structure 20 comprises an inner tube 40 coaxiallymounted within an outer tube 50. The outer tube 50 acts as a tubularconstraint that contains the needles 30 that are typically mounted onthe distal end of the inner tube 50. Although FIG. 2 shows tubes 40 and50 as rigid structures, it should be understood that the tubes 40 and 50may be replaced by structures having different configurations andstiffnesses such as coaxially mounted tubular catheters. The inner tube40 and outer tube 50 are preferably coaxially aligned and are slideablerelative to one another. This slideable relationship may involve movingthe outer tube 50 relative to the inner tube 40 or vice versa. The tubes40 and 50 may also be substantially longer than those shown in FIG. 2.

The shaft structure 20 is typically mounted on the distal end ofelongate housing 60. As shown in FIG. 2, the elongate housing 60 ispreferably connected to an ergonomic handle 70 which allows for bothleft-handed and right-handed use. A trigger 80 may be depressed toreciprocate the tubes 40 and 50 relative to one another. Typically, theinner tube 40 is reciprocated by actuation of the trigger 80. The outertube 50 may be coupled to a plunger that reciprocates the tube between afirst and second position. As shown by phantom lines in FIG. 2, thesuturing device 10 may also include a second shaft structure 90 and atrigger 92 for performing anastomosis on the other end of the graft bodyduct G. It should be understood that the shaft structure 90 may useneedle delivery mechanisms different than that disclosed for the shaftstructure 20. For example, a suturing mechanism such as that describedin commonly assigned, co-pending U.S. patent application Ser. No.08/883,246 (Attorney Docket No. 15508-000150) filed on Jun. 26, 1997,the full disclosure of which is incorporated herein by reference, mayalso be used. Having dual suturing mechanisms on the same anastomosisdevice may reduce the amount of time required to perform the procedureson the patient. The housing 60, the ergonomic grip 70, and the trigger80 may be made of a variety of materials such as stainless steel or amedical grade polymer to reduce the weight of the device. A variety ofother actuating mechanisms beside the trigger 80, such as a pistol griphaving a pivot trigger or a motorized drive mechanism, may also be used.

Referring now to FIG. 3, a suturing procedure using the shaft structure20 will now be described. FIG. 3 shows a perspective view of the shaftstructure 20 having a graft body duct G loaded into the structure. Inthis embodiment, the inner tube 40 has a lumen with a cylindricalsurface that receives the graft body duct G. The curved needles 30 aretypically attached to a distal end 42 of the inner tube 40. The needleshave an arcuate profile as shown in FIG. 3 when the needles areunconstrained. In FIG. 3, the outer tube 50 is retracted or otherwisepositioned to unsheathe the needles 30 so that they may assume theirsubstantially curved configuration or arcuate profile. The inner tube 40has an opening 44 and the outer tube 50 has an opening 54 which allow aproximal end of the body graft G to protrude from the shaft structure20. These openings 44 and 54 facilitate the loading of the body graft Ginto the shaft structure 20. The graft G may be backloaded through thedistal end of the inner tube 40 or loaded in a forward direction throughthe opening 44 in the side of the inner tube 40. As seen in the figure,the body graft G is typically positioned adjacent to the tubularstructure having the needles 30.

Referring now to FIG. 4, with the body graft G properly positioned, theouter tube 50 is advanced to a second position (or the inner tube 40retracted) which sheathes the needles 30 and places them in asubstantially straight configuration. It should be understood, ofcourse, that such relative motion between the tubes may also beaccomplished by retracting the inner tube 40. With the needles 30substantially or completely sheathed, the graft body duct G may bemounted onto the needles by various methods such as everting the graftbody duct G as shown in FIG. 4. The needles 30 are typically advancedforward through the graft body duct G. This loading of the graft bodyduct G and penetration by needles 30 typically occurs in a benchenvironment outside the patient prior to the anastomosis procedure. Avariety of needle guides or graft holders may be used to facilitate theinitial penetration of the graft body duct G by the needles 30.

As shown in FIG. 5, the inner tube 40 may be advanced as indicated byarrow 58 (or the outer tube 50 may be retracted) to drive the needlesthrough the graft body duct G and to expose the needles in theirsubstantially curved configuration. As can be seen in FIG. 5, theneedles have a through hole 32 on which a suture may be attached.Typically, this through hole 32 is located near the sharpened tip of theneedle. In a preferred embodiment, the needles are made of shaped memorymaterial such as a nickel titanium alloy or similar material. In thispreferred embodiment, the needle 30 has a diameter of 0.014 incheshaving a U-shaped bend diameter of approximately 3.1 mm. The length ofthe needle minus the bend 56 as indicated by bracket 57 is approximately5 mm. Although this is the preferred length for penetrating the tissuewall of an aorta A, it should be understood that the length of theneedle may be varied as desired to penetrate a targeted tissue wall. Theinner tube 40 and outer tube 50 may be made of a variety of materialssuch as stainless steal or various medical grade polymers. The innertube 40 has an inner diameter of approximately 3.18 mm and the outerdiameter of 4.11 mm. The outer tube 50 typically has an inner diameterof 4.14 mm and an outer diameter of 4.65 mm. These tubes 40 and 50 maybe sized as desired based on their intended usage.

FIG. 6 shows a cross-section of the shaft structure 20, as indicated bylines 6—6 in FIG. 4, with the graft body duct G loaded therein. Theneedles 30 mounted on the inner tube 40 penetrate through the wall ofthe graft body duct G. The end of the graft G is everted over the end ofthe outer tube 50. This helps the needles 30 penetrate the graft G. Whenthe outer tube 50 moves relative to the inner tube 40, the needles willbegin to curve and travel along the path indicated by phantom lines 62.

As shown in FIGS. 7A and 7B, when the sutured device 10 is used to grafta graft body duct G to the aorta A, a penetration of approximately 4.5mm in diameter for the present embodiment is punched into the aortawall. A breakaway catheter or similar sheathing device 100 is typicallyused to facilitate entry of the shaft structure 20 in a minimallytraumatic manner into the aorta A. Preferably the shaft structure 20 isinserted into the aorta A with the needles in a sheathed, substantiallystraight configuration. Once inside the lumen of the aorta, the needlesare fully extended by retracting the outer tube 50, exposing the needlesin their substantially curved configuration as shown FIG. 7A. As shownin FIG. 7B, the breakaway catheter 100 is removed and the entire shaftstructure 20 is pulled proximally as indicated by arrow 102 such thatthe needles 30 penetrate the aorta wall exposing the sharpened tips ofthe needles. Alternatively, the needles may be deployed from theirsubstantially straight configuration near the wall of the aorta so as tocurve upward and through the aorta wall without substantial movement ofthe shaft structure 20 in the proximal direction 102. Once the needleshave penetrated the aorta wall, the sutures 104 held with an opening 32may be grabbed and removed from the needle tips for knotting to completethe anastomosis. The shaft structure 20, of course, is removed bylowering the shaft structure 20 into the aorta lumen, returning theneedles to their substantially straight configuration within the innertube 50 and withdrawing the shaft structure 20 from the aorta prior tocompletion of the anastomosis. It should be understood that during thedelivery of the needles 30 through the aorta wall, a variety of otherinstruments, such as a vacuum plate or other material, may be used tosupport the peripheral tissue around the hole or opening O to facilitatepenetration by the needles 30. Upon penetration of the aorta tissue, theneedle should create a suture path similar to that shown in FIG. 1B.Such a J-shaped suture path is created by pushing a needle along a paththrough the end of the first body duct inwardly through the hole in theaorta, and then retracting the needle so they penetrate outwardlythrough peripheral tissue surrounding the hole in the aorta. The suturesmay then be secured to attach the graft body duct.

Referring now to FIGS. 8 through 14, another embodiment of a suturingdevice according to the present invention will be described in furtherdetail. As shown in FIG. 8, a suturing device 200 of the presentinvention has a housing 210, a shaft structure 220, and a plungerassembly 230 having a thumb cap 232. In the present embodiment, thesuture device 200 has a guide channel having a first portion 240 and asecond portion 250. These channels 240 and 250 are used to guide needlesof the device 200 along a path similar to that shown in FIG. 1B. Theguide channels 240 and 250 may be integrally formed in the shaftstructure 220 or they may be individual tubular structures. As discussedin regards to FIG. 11, the second portion 250 of the guide channelpreferably has a substantially curved configuration to guide the needlesalong the desired path. The needles contained in the first portion 240of the guide channel in housing 210 are made of materials such as nickeltitanium (NiTi) alloy so as to provide sufficient flexibility to passthrough the curved portions of the guide channels. Of course, theneedles may also be made of a variety of other superflexible or shapememory materials. The elongate members or drive tubes 260 coupled to theplunger 230 can be advanced to drive the needles through the channels inthe housing 210 and through the portions 240 and 250.

The graft G shown in phantom in FIG. 8, is typically loaded onto thedevice 200 by sliding the graft along the shaft structure 220 asindicated by arrow 262. FIG. 9 shows the suturing device 200 with thehousing 210 removed to better illustrate the shaft structure 220,plunger 230, and position of the graft G when loaded. As shown inphantom in FIG. 9, the graft body duct G is loaded onto the shaftstructure 220 so that the graft G preferably does not cover openings 252of the channels 250. The shaft structure 220 has a surface 221 adaptedto receive the graft body duct G. Although the device 200 of FIG. 8shows the present device with a syringe-type configuration, it should beunderstood that a variety of other driving mechanisms, such as aratcheting pistol grip or a motorized needle driver, may be used todeploy the needles of the present invention. As seen in FIG. 10, theelongate members or drive tubes 260 contact the flexible needles 270 toadvance the needles through a guide tube 280 or channel within thehousing 210. Each needle 270 preferably carries a suture 272 that issecured near the proximal end of the needle. In preferred embodiments,the suture 272 extends within a lumen of the elongate member 260. Theplunger 230 and/or the thumb cap 232 typically acts as suture storageareas for the needles 270 of the present device. It should beunderstood, of course, that in alternative embodiments, the suture 272may also be connected to the sharpened distal tip of the needle 270.

Referring now to FIG. 11, a cross-sectional view of the distal tip ofdevice 200 will now be described. As seen in the figure, needle 270 isadvanced through the first portion 240 of the guide channels. The firstportion 240 is located on an outer side of the graft body duct G and hasan opening 241 positioned to open towards the graft body duct G. Theneedle 270 passes through the wall of graft G and into the secondportion 250 of the guide channel located on the inner side of the graft.The needle 270 is of sufficient flexibility to pass through thepreferably curved configuration of the second portion 250 and out theopening 251. In preferred embodiments, the second portion 250 has aJ-shaped section to evert needles passing through the guide channel. Theneedle 270 is everted at bend 252 which directs the needle outwardtowards tissue peripheral to an opening O made in a targeted body ductsuch as the aorta. The sharpened distal end is pointed proximallytowards the tissue surrounding the opening O in the second body duct B.Preferably, the needle 270 is of sufficient length to penetrate throughthe wall of the body duct B before the elongate member or drive tube 260enters the curved portion of first channel 240.

As shown in FIG. 12, once the needle 270 has penetrated through the wallof the targeted body duct B, the needle 270 is completely removed fromthe suture device 200 as indicated by arrow 290 and the sutures releasedfrom the J-shaped channels 250. Release of the sutures from the secondportion 250 of the guide channel allows for the removal of the device200 once the needles have established a suture path such as that shownin FIG. 1B. As more clearly shown in FIG. 13, each J-shaped channel 250preferably has a longitudinal slot 292 extending along the entire lengthof the J-shaped channel. This creates a tube having a C-shapedcross-section as shown in FIG. 14. The slot 292 is of sufficient size toallow for suture removal, but is not of sufficient size to allow aneedle 270 to be removed through the slot 292. For example in oneembodiment, the slot 292 is about 0.006 inches wide, the channel 250 hasan inside diameter of about 0.013 inches, and the needle 270 has adiameter of about 0.010 inches. Once the device 200 has been removed,the sutures 272 may be knotted to complete the anastomosis. The guidechannels 240 and 250 and tube 260 may be made of stainless stealhypotube, but it should be understood that other materials, such asvarious hardened polymers, may also be used as desired. It should beunderstood that the needles are typically advanced until the distalsharpened tip can be visually observed breaking through the wall of abody duct B such as the aorta. It should also be understood that thedevice 200 may also be mounted on a pistol grip in a manner similar tothat shown for a suture device 10 of FIG. 2.

Referring now to FIG. 15, the suturing device 10 of the presentinvention will usually be packaged in kits. In addition to the suturingdevice 10, such kits will include at least instructions for use 300(IFU). The suturing device and instructions for use will usually bepackaged together within a single enclosure, such as a pouch, tray, box,tube, or the like 302. In alternative embodiments, the kit may include asuturing device 200 in place of the suturing device 10. Some kits mayalso include the graft G to be sutured to a target vessel. Such grafts Gare typically artificial or synthetic. At least some of the componentsmay be sterilized within the container. Instructions for use 300 willset forth any of the methods described above.

While all the above is a complete description of the preferredembodiments of the inventions, various alternatives, modifications, andequivalents may be used. For example, other embodiments of the presentinvention may have fewer or additional numbers of needles mounted on thedistal tip of the suturing device. The needles 30 may have a releasableconnection with the inner tube 40. The device may also have othersuturing mechanisms such as other end-to-side or side-to-side suturingdevices attached to the same pistol grip mounting device to facilitateattachment of a distal end of the graft body duct. The size of the guidetubes used with the needles may be adjusted based on the size/diameterof the needle used. The suturing device may also be equipped withstructure to maintain perfusion in the targeted blood vessel. In furtheralternative embodiments, the suturing device may pass the needle throughthe targeted body duct first and then through the graft body duct byreversing the direction shown in FIG. 2. Such a device would have aneedle drive which delivers its needle through the tissue of thetargeted body duct and then into opening 251 to travel up through theJ-shaped tube.

Although the foregoing invention has been described in detail forpurposes of clarity of understanding, it will be obvious that certainmodifications may be practiced within the scope of the appended claims.

1. A device for suturing an end of a first body duct to a hole in theside of a second body duct, said device comprising: a shaft for holdingthe end of the first body duct and positioning said end adjacent to thehole in the side of the second body duct; and a plurality of needlesarranged on the shaft to be advanced alone a plurality of paths, whereinthe shaft has a tubular surface against which the needles are positionedto guide said needles along said path, each path being configured topass radially into and forwardly out of the end of the first body ductand into the hole of the second body duct and then everts so that theneedles will pass outwardly through tissue peripheral to the hole whenthe end of the first body duct is on the shaft adjacent to the hole inthe second body duct.
 2. A device as in claim 1, wherein the shaftfurther comprises a plunger for advancing said needles through the firstbody duct.
 3. A device as in claim 2, wherein the plunger includessuture storage for a plurality of sutures each coupled to one of saidplurality of needles.
 4. A device as in claim 2, wherein the plungercomprises a plurality of elongate members for advancing said needlesthrough the first body duct.
 5. A device as in claim 4, wherein theelongate members comprise tubes each containing a suture coupled to oneof said needles.
 6. A device as in claim 1, wherein the shaft comprisesa plurality of guide channels which define said plurality of paths.
 7. Adevice as in claim 6, wherein the guide channels are arranged in aradial configuration about the shaft.
 8. A device as in claim 6, whereinthe guide channels comprise guide tubes.
 9. A device as in claim 6,wherein the guide channels have a longitudinal slot along a length of atleast of one said guide channels.
 10. A device as in claim 6, whereinthe guide channels each have a first portion and a second portion,wherein the first and second portions are separated by a gap configuredto receive the end of the first body duct.
 11. A device as in claim 10,wherein the second portion of the guide channel comprises a guide tubehaving a J-shaped section for guiding one of said needles along aportion of said path.
 12. A device as in claim 11, wherein the secondportion of the guide channel tube has a longitudinal slot extendingalong the length of the guide tube having a j-shaped section.
 13. Adevice as in claim 10, wherein: the first portion of the guide channelis adapted to be positioned outside the first body duct and has a distalopening positioned to open towards an outer surface of the first bodyduct when the first body duct is mounted on the shaft; and the secondportion of the guide channel is adapted to be positioned within a lumenof the first body duct when the first body duct is mounted on the shaft,said second portion of the guide channel receiving one of said needlesadvanced from the first portion and passing through a body duct wall.14. A device as in claim 13, wherein the second portion of the guidechannel has a j-shaped configuration.
 15. A device as in claim 13,wherein the second portion of the guide channel includes a longitudinalslot extending the length of the second portion.
 16. A device as inclaim 13, wherein the needles are of sufficient length to extend fromthe first portion of the guide channel, through the second portion, andthrough a tissue layer of the second body duct.
 17. A device as in claim6, wherein at least one of said guide channels has a substantiallycurved configuration so that one of said needles passing through saidguide channel will evert to pass outwardly through tissue peripheral tothe hole when the end of the first body duct is on the shaft adjacent tothe hole in the second body duct.
 18. A device as in claim 1, whereinsaid needles comprise a shape-memory alloy.
 19. A device as in claim 1,wherein said needles comprise a superelastic material.
 20. A device asin claim 1, wherein: said needles each have an arcuate profile whenunconstrained; said structure comprises a tubular constraint having alumen surface, wherein the needles are movable between a first positionwithin the tubular constraint where said needles have a substantiallystraight configuration and a second position within the constraintwherein said needles extend beyond the tubular constraint and assumesaid arcuate profile.
 21. A device as in 20, wherein said tubularconstraint comprises an inner tube coaxially mounted with an outer tube,said needles mounted on the distal end of the inner tube wherein saidinner tube is movable between a first and second position with the outertube.
 22. A device as in claim 1, wherein the shaft comprises: an outertube having a passage; and an inner tube slidably mounted in the passageof the outer tube and having the needles fixedly secured to a distal endthereof, said needles adapted to penetrate one end of the first bodyduct when the body duct is mounted within said inner tube.
 23. A deviceas in claim 22, wherein: said needles each have an arcuate profile whenunconstrained; said inner tube is movable between a first positionwithin the outer tube where said needles have a substantially straightconfiguration and a second position within the outer tube wherein saidneedles extend beyond the outer tube and assume said arcuate profile.24. A device as in claim 22, wherein the inner tube has an opening in awall of the inner tube spaced apart from a distal end of the inner tube,said opening allowing for the insertion of the first body duct into alumen of the inner tube.
 25. A device as in claim 22, wherein the innertube is coupled to a plunger which reciprocates said inner tube betweena forwardly advanced position and a retraifled position.
 26. A device asin claim 22, wherein the outer tube and inner tube are in coaxialalignment and have a slideable relationship relative to each other. 27.A device as in claim 22, wherein each of said needles has a sutureattached to the distal end of said needles.
 28. A device as in claim 22,wherein the needles have arcuate shape memory so that they evert as theyare advanced forward.
 29. A device as in claim 28, wherein the needleshave a sharpened tip pointing proximally when the needles are in asubstantially curved configuration.
 30. A device as in claim 28, whereinsaid needles comprise a shape memory material.
 31. A device as in claim22, wherein the needles in said second position has a length sufficientto extend from the inner tube through a wall of the second body ductsuch that a sharpened tip of the needle penetrates completely throughsaid wall.
 32. A device as in claim 22, wherein the needles have areleasable connection with said inner tube.
 33. A device as in claim 1,further comprising means for guiding said needles through the first andsecond body ducts.
 34. A device as in claim 33, wherein the means forguiding the needles comprises a plurality of guide channels.
 35. Adevice as in claim 33, wherein the means for guiding the needlescomprises a plurality of needles having an arcuate profile whenunconstrained and mounted within a tubular constraint, said needlesmovable between a first position where the tubular constraint forces theneedles to a substantially straight configuration and a second positionwherein the needle assumes a configuration exhibiting said arcuateprofile.